Kyinsu (insulin icodec;semaglutide)
- Region
- 🇪🇺 EU
- Active substance
- insulin icodec;semaglutide
- Company
- Novo Nordisk A/S
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 18 Sep 2025
- EU approval
- Mon 24 Nov 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006279
- ATC
- A10AE57
- Official record
- www.ema.europa.eu
Indication
Kyinsu is indicated for the treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products. For study results with respect to combinations, effects on glycaemic control, and the populations studied, see sections 4.4, 4.5 and 5.1.
Regulatory milestones
Kyinsu (insulin icodec;semaglutide) approved in the EU
Marketing authorisation to Novo Nordisk A/S; Additional monitoring · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.